AccessGUDID - DEVICE: BD SurePath (00382904905408)

GUDID

Device Identifier (DI) Information

Brand Name: BD SurePath
Version or Model: 490540
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 490540
Company Name: TRIPATH IMAGING, INC.

Primary DI Number: 00382904905408
Issuing Agency: GS1
Commercial Distribution End Date: August 26, 2015
Device Count: 1
Labeler D-U-N-S® Number*: 103318015 *Terms of Use

Device Description: SurePath® GYN Collection Kit contains 100 collection vials used to preserve, transport, and store cevical cytology samples.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
12955	Papanicolaou smear kit	A packaged collection of instruments, equipment, and reagents required to obtain a cytology sample from the cervix and perform a Papanicolaou test (PAP). Commonly known as a Pap smear or Pap test the cells are typically smeared onto a microscope slide or mixed in a liquid fixative for microscopic examination. A Pap test is usually done as part of a woman's regular pelvic examination. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MKQ	Processor, Cervical Cytology Slide, Automated

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P970018	001

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Height: 32.5 Centimeter
Width: 31.5 Centimeter
Length: 51.5 Centimeter

Device Record Status

Public Device Record Key: 6caa0185-1e58-45e6-82c0-cab781224d48
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 22, 2015